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New Medicines

Roclanda [EU], Rocklatan [US]Glaucoma to lower intraocular pressure (IOP) in patients with glaucoma or ocular hypertension

Information

Roclanda [EU], Rocklatan [US]
New formulation
Aerie Pharmaceuticals
Aerie Pharmaceuticals

Development and Regulatory status

Licensed but not launched
Licensed but not launched
Launched
Jun 21Company hoping to launch in the UK by and before end of 2022 but cannot guarantee any dates [18]
May 21Licensed in UK [17].
Jan 21Approved in EU [16].
Nov 20Recommended for EU approval by CHMP - the full indication is "for the reduction of elevated intraocular pressure (IOP) in adult patients with primary open-angle glaucoma or ocular hypertension for whom monotherapy with a prostaglandin or netarsudil provides insufficient IOP reduction” [14].
Jan 20As with Rhokiinsa, UK launch likely to be delayed post licensing due to the time needed for implementing the EU manufacturing process [13]
Dec 19Aerie Pharmaceuticals file a MAA with EMA [12].

May 19: Launched in the US. The Mercury 3 trial has been designed to facilitate regulatory approval and commercialisation in Europe. This trial is due for completion Nov 19 [10,11].


Mar 19: approved in the US with the indication "for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension" [8].


May 18: Filed in the US [7]


May 17: based on the results of the Mercury 2 study, Aerie intend to file in the US early in 2018. The Mercury 3 trial, intended to provide data for EU registration, is now expected to begin in Europe mid-2017 [6]: based on the duration of Mercury 2, primary outcome results would be expected mid to late 2018.


Sep 16: following promising results from MERCURY 1 trial, the company expects to file for US approval towards the end of 2017 [3]. It expects to initiate the MERCURY 3 trial to assist in EU filing during the first half of 2017 and is seeking partners to commercialise the product outside the US [4].


Sep 15: Aerie will initiate two additional PIII trials in 2016. Mercury 2 will be a second registration trial in the US structured similarly to Mercury 1 and designed to measure efficacy over 90 days. In addition, Mercury 3 will be a third registration trial in Europe designed to assist with European approval, and is expected to be a non-inferiority trial comparing Roclatan to a widely prescribed fixed-dose combination product marketed in Europe [2].

Category

Once daily AR-13324 has a triple mechanism of action leading to reduced aqueous humour production, decreased episcleral venous pressure and increased fluid outflow through the trabecular meshwork. Plus prostaglandin analogue, latanoprost.
Glaucoma is one of the most common eye conditions encountered in primary and secondary care. In the UK, glaucoma is the second most common cause for registration of visual impairment, accounting for 9-12% of registrations in people over the age of 65 years.Primary open-angle glaucoma (POAG) is the most common type of glaucoma, accounting for over 70% of cases. Ocular hypertension affects 3-5% of the population over 40 years of age but only a small proportion of these people develop glaucoma [1]
Glaucoma to lower intraocular pressure (IOP) in patients with glaucoma or ocular hypertension
Topical

Further information

Yes

Trial or other data

Sep 20Interim 90-days top-line efficacy results from the PIII Mercury 3 trial showed treatment with latanoprost/netarsudil achieved primary efficacy endpoint of non-inferiority to bimatoprost/timolol. Latanoprost/netarsudil demonstrated consistent IOP reduction throughout the day of approx 9.5 mmHg for an average reduction from baseline IOPs of approximately 37%. IOP reductions in Mercury 3 trial exceeded both Mercury 1 and Mercury 2 [15].

Jul 18: Mercury 3 trial estimated primary completion now November 2019; recruitment now includes UK [9].


Sep 17: Aerie announced enrolment of first patient in the PIII Mercury 3 trial (EudraCT2015-001528-41). The two-arm, six-month safety trial is intended to enrol approximately approximately 500 patients in the UK, France, Germany, Italy, Spain, and Belgium. The trial will also provide a 90-day interim efficacy readout comparing once-daily latanoprost/netarsudil mesylate (0.005%/0.02%) for non-inferiority to bimatoprost/timolol which is expected to be announced by early 2019. Patients will be evaluated with maximum baseline IOPs ranging from >20 to <36 mmHg [7].


May 17: topline results of the Mercury 2 trial have been announced by the company: the combination product showed statistical superiority in lowering intraocular pressure (IOP) over each of the component drugs. According to the data, the effect of the combination "exceeded that of latanoprost in a range of 1.5 to 2.4 mmHg for an average of 1.8 mmHg, and exceeded Rhopressa IOP lowering in a range of 2.2 to 3.3 mmHg for an average of 2.7 mmHg." It also reduced mean diurnal IOPs to 16 mmHg or lower in 56 percent of patients, a significantly higher percentage than observed in the two comparator arms [6].


Mar 16: the MERCURY 2 trial (NCT02674854) is initiated; study design is similar to MERCURY 1 and expected completion date for the primary outcome is February 2017 [4,5].


Sep 16: Aerie announce positive initial data from the MERCURY 1 trial (NCT02558400), which completed enrolment in May 2016 [3].


Sep 15: Aerie announce that dosing commenced of the first patients enrolled in Mercury 1, a PIII registration trial of Roclatan. Aerie anticipates total enrolment of approximately 690 patients in this three-arm one-year safety study with a 90-day efficacy readout. Roclatan demonstrated in its successful P2b clinical trial in 2014 that it has the potential to be the most efficacious therapy for patients with glaucoma and ocular hypertension. The clinical endpoint of Mercury 1 is similar to the efficacy endpoint in the previous P2b clinical trial and compares Roclatan for superiority over each of its two components, with all three arms dosed once daily. The range for the primary endpoint evaluates patients with maximum baseline IOPs ranging from above 20 to below 36 mmHg (millimeters of mercury). The 90-day efficacy results of this study are expected to be reported in approximately one year [2].

Evidence based evaluations